European Journal of Cardio-Thoracic Surgery Advance Access published February 3, 2015

ORIGINAL ARTICLE

European Journal of Cardio-Thoracic Surgery (2015) 1–8 doi:10.1093/ejcts/ezv014

Aortic valve replacement through full sternotomy with a stented bioprosthesis versus minimally invasive sternotomy with a sutureless bioprosthesis Magnus Daléna,b,*, Fausto Biancaric, Antonino S. Rubinod, Giuseppe Santarpinoe, Natalie Glasera,b, Herbert De Praeteref, Keiichiro Kasamaf, Tatu Juvonenc, Wanda Dested, Francesco Pollarie, Bart Meurisf, Theodor Fischleine, Carmelo Mignosad, Giuseppe Gattig, Aniello Pappalardog, Peter Svenaruda,b,† and Ulrik Sartipya,b,† a b c d e f g

Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden Department of Cardiothoracic Surgery and Anesthesiology, Karolinska University Hospital, Stockholm, Sweden Department of Surgery, Oulu University Hospital, Oulu, Finland Cardiac Surgery Unit, A.O.U. Policlinico-Vittorio Emanuele, University of Catania, Catania, Italy Department of Cardiac Surgery, Klinikum Nürnberg, Paracelsus Medical University, Nuremberg, Germany Department of Cardiac Surgery, University Hospital Gasthuisberg, Leuven, Belgium Division of Cardiac Surgery, Ospedali Riuniti, Trieste, Italy

* Corresponding author. Department of Cardiothoracic Surgery and Anesthesiology, Karolinska University Hospital, SE-171 76 Stockholm, Sweden. Tel: +46-8-51770837; fax: +46-8-331931; e-mail: [email protected] (M. Dalén). Received 16 October 2014; received in revised form 29 December 2014; accepted 6 January 2015

Abstract OBJECTIVES: The aim of this study was to analyse early postoperative outcomes and 2-year survival after aortic valve replacement (AVR) through a ministernotomy with a sutureless bioprosthesis implantation compared with a full sternotomy with implantation of a stented bioprosthesis. METHODS: Patients who underwent primary isolated non-emergent AVR at six European centres were included in the study. Of these, 182 (32%) underwent a ministernotomy with a sutureless bioprosthesis (ministernotomy sutureless group) and 383 (68%) a full sternotomy with a stented bioprosthesis (full sternotomy stented group). Propensity score matching was used to reduce selection bias. RESULTS: In the overall cohort, 30-day mortality was 1.6 and 2.1%, and 2-year survival was 92 and 92% in the ministernotomy sutureless group and in the full sternotomy stented group, respectively. Propensity score matching resulted in 171 pairs with similar characteristics and operative risk. Aortic cross-clamp (40 vs 65 min, P < 0.001) and cardiopulmonary bypass time (69 vs 87 min, P < 0.001) were shorter in the ministernotomy sutureless group. Patients undergoing ministernotomy received less packed red blood cells but the risk for postoperative permanent pacemaker implantation was higher. There were no differences regarding 30-day mortality or 2-year survival between the two groups. CONCLUSIONS: AVR through a ministernotomy with implantation of a sutureless bioprosthesis was associated with shorter aortic crossclamp and cardiopulmonary bypass time and less transfusion of packed red blood cells, but a higher risk for postoperative permanent pacemaker implantation compared with a full sternotomy with a stented bioprosthesis. Keywords: Aortic valve replacement • Minimally invasive surgery • Ministernotomy • Sutureless

INTRODUCTION Minimally invasive aortic valve replacement (AVR) through a ministernotomy has been developed as an alternative approach to conventional full sternotomy AVR. The technique was developed to reduce surgical trauma and studies have demonstrated favourable postoperative outcomes compared with full sternotomy AVR [1–5]. †

U.S. and P.S. contributed equally.

However, minimally invasive AVR is associated with a reduction of surgical exposure and working space, resulting in a more technically challenging procedure compared with conventional AVR, which has led to questioning of the safety of the procedure. The more complex implantation is associated with prolonged aortic cross-clamp and cardiopulmonary bypass time [1, 2], which has been related to worse postoperative outcomes [6–9]. It has been hypothesized that the longer procedural times compared with full sternotomy AVR attenuate the benefits of

© The Author 2015. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

ADULT CARDIAC

Cite this article as: Dalén M, Biancari F, Rubino AS, Santarpino G, Glaser N, De Praetere H et al. Aortic valve replacement through full sternotomy with a stented bioprosthesis versus minimally invasive sternotomy with a sutureless bioprosthesis. Eur J Cardiothorac Surg 2015; doi:10.1093/ejcts/ezv014.

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M. Dalén et al. / European Journal of Cardio-Thoracic Surgery

minimally invasive incisions [10] and ways to shorten procedural time may be of great importance for the success of minimally invasive AVR. During recent years, sutureless aortic bioprostheses were introduced. These prosthetic valves were designed to facilitate implantation, and thus reduce operative and myocardial ischaemia time and previous studies have demonstrated excellent postoperative outcomes [11–15] and reduced aortic cross-clamp and cardiopulmonary bypass time compared with implantation of conventional stented bioprostheses [12, 14]. Sutureless bioprostheses may substantially facilitate minimally invasive AVR, and thereby reduce the risks associated with prolonged myocardial ischaemia. There are no previous studies comparing the risks and benefits of current era minimally invasive AVR using sutureless bioprostheses with conventional AVR through full sternotomy with stented valves. Combining the advantages of minimally invasive surgical techniques with implantation of sutureless bioprosthetic valves is theoretically appealing, and might improve AVR postoperative outcomes. The aim of this study was to analyse early postoperative outcomes and 2-year survival after AVR performed through a ministernotomy with sutureless bioprosthesis implantation compared with a full sternotomy with implantation of a stented bioprosthesis.

MATERIALS AND METHODS This study was approved by a human research ethical review board at each participating centre.

Study design and study population This was an analysis of two consecutive series of patients who underwent primary isolated non-emergent AVR at six European centres. Patients who underwent AVR through ministernotomy with sutureless bioprosthesis were operated on from June 2007 to April 2014 at six European centres (Belgium, Finland, Germany, Catania and Trieste in Italy and Sweden). Sutureless bioprostheses in combination with full sternotomy were performed infrequently when compared with sutureless bioprostheses through a ministernotomy. Sutureless valve implantation through a full sternotomy was mostly performed in the beginning of each centre’s sutureless valve programme, so that the surgeons would be familiar with sutureless valve implantation before proceeding with minimally invasive approaches. Patients who underwent AVR through full sternotomy with stented bioprosthesis were operated at Karolinska University Hospital, Stockholm, Sweden between January 2005 and December 2010. The inclusion criterion was severe aortic stenosis with indication for primary isolated non-emergent AVR with the use of the Perceval sutureless bioprosthesis made of bovine pericardium mounted on a nitinol stent (Sorin Biomedica Cardio Srl, Salluggia, Italy) or the Carpentier-Edwards Perimount stented bioprosthesis made of bovine pericardium (Edwards Lifesciences, Irvine, CA, USA). Patients who had previous cardiac surgery, active endocarditis or a concomitant cardiac procedure in addition to AVR were excluded. Implantation with the Perceval prosthesis was considered feasible if the aortic annulus size was between 19 and 27 mm and the ratio between the diameter of the sinotubular junction and the diameter of the aortic annulus did not exceed 1.3. Data on patients’ characteristics and operative details were retrieved retrospectively from patients’ medical records. The follow-up data were retrieved from national

registries, by reviewing hospital records or contacting the patient or his/her physician.

Outcome measures The primary outcome measures of this study were all-cause 30-day mortality and 2-year survival. Secondary outcome measures were aortic cross-clamp time, cardiopulmonary bypass time, paravalvular regurgitation, transfusions of packed red blood cells, reoperation for paravalvular regurgitation, reoperation for bleeding, de novo dialysis, permanent pacemaker implantation and intensive care unit stay.

Ministernotomy with sutureless bioprosthesis A 6- to 10-cm midline skin incision was made over the upper part of the sternum. A partial J-shaped ministernotomy in the third to fourth intercostal space or a V-shaped ministernotomy at the level of the second intercostal space was performed. Cardiopulmonary bypass was established with central arterial and central or peripheral venous cannulation. Antegrade crystalloid or cold blood cardioplegia was used. The ascending aorta was incised transversally 1.5 cm above the sinotubular junction. The aortic valve was excised and the aortic annulus completely decalcified. The manufacturer’s sizer was used for selecting the appropriate bioprosthetic valve size. Three guiding 4-0 polypropylene sutures were placed at the nadir point of each valve sinus. At back table, the Perceval prosthesis was collapsed using a specific device system. The prosthesis was attached to the guiding threads through the three loops at the proximal ring of the prosthesis and the deployment system was positioned into the aortic root and the valve released into the aortic annulus. A balloon was inserted into the prosthesis and dilated at a pressure of 4 atmospheres for 30 sec. The three guiding sutures were removed and the aortotomy was closed using running sutures. After weaning from cardiopulmonary bypass, transoesophageal echocardiography was performed to confirm correct positioning of the prosthesis and for the detection of any paravalvular regurgitation.

Full sternotomy with stented bioprosthesis A full median sternotomy, cardiopulmonary bypass with central arterial and venous cannulation, and antegrade or retrograde, or both, cold blood cardioplegia were used. In all patients, the stented Carpentier-Edwards Perimount bioprosthesis was used. The manufacturer’s sizer was used for selecting the appropriate bioprosthetic valve size.

Statistical analysis Independent samples t-test and χ 2 test were used for univariate analyses in the overall cohort, and paired samples t-test and univariate conditional logistic regression was used in the propensity score matched cohort. The model included only the variable/ characteristic/outcome of interest and an indicator variable for the ministernotomy sutureless group. The Kaplan–Meier method was used to calculate cumulative survival and to construct survival curves and the log-rank test was used to compare differences between the curves. To reduce selection bias, a propensity score was calculated for each patient by logistic regression. A propensity

M. Dalén et al. / European Journal of Cardio-Thoracic Surgery

and 383 (68%) patients with a stented bioprosthesis through a full sternotomy. The study included all ministernotomy sutureless implantations at the participating centres and patients were censored at last contact date. Therefore, there was no loss to the followup in the ministernotomy sutureless group. The full sternotomy stented group was a consecutive series of patients implanted with the Perimount stented bioprostheses and vital status was ascertained on 15 March 2013 in the Total Population Register (National Board of Health and Welfare, Sweden) and there was no loss to the follow-up.

score-matched cohort was constructed by nearest neighbour matching without replacement, one ministernotomy sutureless bioprosthesis patient to one full sternotomy stented bioprosthesis patient. We calculated standardized differences for variables to investigate post-match balance. Standardized differences 85 (ml/min) 50–85 (ml/min) 50% 30–50%

Aortic valve replacement through full sternotomy with a stented bioprosthesis versus minimally invasive sternotomy with a sutureless bioprosthesis.

The aim of this study was to analyse early postoperative outcomes and 2-year survival after aortic valve replacement (AVR) through a ministernotomy wi...
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